DQS offers various services in the field of approval of medical devices and certification of management systems in healthcare.

MDSAP- Medical Device Single Audit Program

The Medical Device Single Audit Program (MDSAP) offers the opportunity to demonstrate compliance with the regulatory requirements of up to five participating countries through a certification process: Australia, Brazil, Japan, Canada and the USA. The advantages of the program are not only the recognition of the results in the registration of medical devices but also the reduction of on-site inspections by the participating authorities.

Health care certifications

ISO 9001, ISO 13485, MDSAP, ISO 15378

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CE marking: Notes on handling unannounced audits

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MED Präsentationsfolien
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Change of certifier and/or notified body

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MED unannounced audits

ISO 13485

ISO 13485:2016 defines the requirements for a quality management system to demonstrate an organization's ability to provide medical devices and related services that consistently meet the requirements of both customers and applicable regulatory provisions.

Primary packaging materials for medicinal products

ISO 15378

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MED Präsentationsfolien
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Change of certifier and/or notified body

CE marking

MDR (EU) 2017 / 745

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CE marking: Notes on handling unannounced audits

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Flatten the Curve
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Flatten-the-Curve? From 2023, the big wave of MDR certifications will be rolling in for notified bodies

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MED Präsentationsfolien
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Change of certifier and/or notified body

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MED unannounced audits